BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RITLENG PROBE

    MDR report key: 1595322 · Received January 30, 2010

    Report

    Report Number
    1595322
    Event Type
    Injury
    Date Received
    January 30, 2010
    Date of Event
    November 13, 2009
    Report Date
    November 20, 2009
    Manufacturer
    FCI OPHTHALMICS
    Product Code
    HNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY FOR BILATERAL PROBE AND IRRIGATION WITH SILICONE INTUBATION OF LACRIMAL DUCTS, THE PHYSICIAN NOTICED THAT THE LACRIMAL DUCT INSTRUMENT PROBE TIP WAS MISSING. HE HAD INSERTED THE TUBE ON THE RIGHT SIDE AND NOTICED THAT THE INSTRUMENT TIP WAS MISSING WHILE INSERTING THE TUBE ON THE LEFT SIDE. WHILE IN THE PACU, AN X-RAY WAS TAKEN AND THE PHYSICIAN AND ANESTHESIOLOGIST ASSESSED THAT THE INSTRUMENT TIP WAS IN THE PT'S LEFT NASAL AREA. THE PT WAS RETURNED TO THE OPERATING ROOM FOR POSSIBLE RETRIEVAL / REMOVAL OF THE BROKEN INSTRUMENT PROVE TIP. THE PHYSICIAN PERFORMED EXPLORATORE LEFT NASAL ENDOSCOPIC SURGERY WITHOUT IDENTIFYING THE FOREIGN BODY. FLUOROSCOPY OF THE HEAD AREA PERFORMED IN THE OPERATING ROOM ALSO WITHOUT IDENTIFICATION OF FOREIGN BODY. ANESTHESIOLOGIST EXAMINED CONTENTS OF SUCTION CANNISTER. NO OPERATIVE COMPLICATIONS - PT TOLERATED PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RITLENG PROBE RITLENG PROBE HNL FCI OPHTHALMICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention CRAWFORD HOOK| MONOKA MONOCANALICULAR STENT